Panel Discussion: Best practices in analytical QbD

In this video:
+ Dr Ranjit Barshikar, CEO-QbD International; United Nations Adviser – Geneva (Moderator)
+ Dr Sujay Rajhans, President & Head of R&D, JB Chemicals & Pharmaceuticals
+ Dr Sandeep Zokande, VP – Analytical, Indoco Remedies
+ Dr Shakil Sait, Associate VP-Analytical Development (API & Formulation), USV
+ Dr Amarnath Chatterjee, Sr Lead Investigator & Head Analytical Development Biologics, Syngene International Ltd

Key Highlights:
+ Lifecycle approach is important as that is where the regulators are focussing today: Dr Ranjit Barshikar, CEO, QbD International; United Nations Adviser – Geneva (Moderator)

+ The next decade is going to be a big thing in terms of pharma quality with the help of QbD: Dr Sujay Rajhans, President and Head – R&D, JB Chemicals and Pharmaceuticals

+ When pharmacopoeia standards are not suitable, companies design a method which is superior to these standards. QbD is such an approach that is designed based on science: Dr Sandeep Zokande, VP – Analytical, Indoco Remedies

+ It is important to incorporate ATPs and CQAs while designing a method, and that’s where QbD becomes important, especially for biologics: Dr Amarnath Chatterjee, Sr Lead Investigator and Head – Analytical Development Biologics, Syngene International

+ An improper design screening of analytical methods has been creating a lot of method-related issues. Implementation of a QbD will make the life of our developers and QC analysts easier: Dr Shakil Sait, Associate VP – Analytical Development (API & Formulation), USV